NCT05153928Unknown不适用
Management of Uterine Leiomyomata and Adenomyosis : Role of Hysteroscopy in Diagnosis and Norethisterone in the Treatment
Ahmed Ali Mahmoud2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis
研究概览
简要总结
- to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
- to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma
详细描述
The aim of the present study is:
- to determine the role of hysteroscopy and guided biopsy to differentiate between submucosal fibroids and adenomyosis confirmed by histopathological examination
- to evaluate the efficacy of norethisterone in the treatment of symptomatic adenomyosis and leiomyoma
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(1) age≥30 years; (4) dysmenorrhea, adenomyosis-associated chronic pain, and/or menorrhagia.
- •(3) regular menstrual cycles before administration of norethisterone; (4) no other treatment for adenomyosis/leiomyomatosis at least for 3 months biopsies and histopathology for operated patients;
排除标准
- •(1) pregnant and/or breast-feeding women (2) patients with a ovarian neoplasm, benign ovarian cyst including endometrioma, pelvic inflammatory disease or other endocrine diseases.
研究组 & 干预措施
fibroid cases
Norethisterone acetate for 5 months
干预措施: Norethisterone acetate (Drug)
adenomyosis
Norethisterone acetate for 5 months
干预措施: Norethisterone acetate (Drug)
结局指标
主要结局
is to evaluate sensitivity and specificity of hysteroscopy in differentiating between uterine adenomyosis and leiomyomatosis
时间窗: 6 months
Symptomatic improvement
次要结局
未报告次要终点
研究者
Ahmed Ali Mahmoud
Dr
Assiut University
研究点 (2)
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